Callender, Valerie D. http://orcid.org/0000-0003-1297-5270
Alexis, Andrew F.
Stein Gold, Linda F.
Lebwohl, Mark G.
Paller, Amy S.
Desai, Seemal R.
Tan, Huaming
Ports, William C.
Zielinski, Michael A.
Tallman, Anna M.
Funding for this research was provided by:
Pfizer Inc.
Article History
First Online: 1 July 2019
Compliance with Ethical Standards
:
: This study was funded by Pfizer Inc.
: Valerie D. Callender is an advisor and speaker for Pfizer. Andrew F. Alexis has received grants from Galderma, Novartis, Almirall, RXi Pharmaceuticals, Bristol-Myers Squibb, Celgene, Menlo, and LEO Pharma and consulting fees or honoraria from Pfizer, Novartis, Almirall, Menlo, Trevi, Dermavant, Unilever, Celgene, BiopharmX, Cipla, Beiersdorf, Valeant, Galderma, Sanofi-Genzyme, and LEO Pharma. Andrew F. Alexis has also received writing assistance, medicines, equipment, or administrative support from Pfizer and payment for lectures from Pfizer and LEO Pharma. Linda F. Stein Gold has received grants from Pfizer, LEO Pharma, and Incyte, and payment for lectures from Pfizer and LEO Pharma. Mark G. Lebwohl is an employee of Mount Sinai and has received research funds from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, LEO Pharma, MedImmune/AstraZeneca, Novartis, Pfizer, SCIderm, Valeant, and Vidac Pharma. Mark G. Lebwohl is also a consultant for Allergan, Aqua Pharmaceuticals, Boehringer Ingelheim, LEO Pharma, Menlo, Mitsubishi, Promius, and Verrica. Amy S. Paller has been an investigator for AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Sanofi-Regeneron, and has been a consultant with honoraria for AbbVie, Amgen, Asana BioSciences, Dermavant, Dermira, Galderma, Eli Lilly, Forte, LEO Pharma, Matrisys Bioscience, Menlo, MorphoSys/Galapagos, Novartis, Pfizer, and Sanofi-Regeneron. Seemal R. Desai has received consulting fees or honoraria and payment for lectures from Pfizer. Huaming Tan, William C. Ports, and Michael A. Zielinski are employees and stockholders of Pfizer Inc. Anna M. Tallman was an employee and stockholder of Pfizer Inc. at the time of the analysis and initial manuscript development.
: All study procedures involving human participants were performed in accordance with all applicable laws, rules, and regulations, including the principles of Good Clinical Practice and the ethical principles outlined in the 1964 Helsinki Declaration and its later amendments.
: Informed consent was obtained from all study participants, and the institutional review board of each investigational center approved all study protocols, consent forms, and relevant supporting data. This article does not contain any studies with animals performed by any of the authors.
: Upon request, and subject to certain criteria, conditions and exceptions (seeExternalRef removedfor more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the United States and/or European Union or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.